Device recall
TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
- Recall number
- Z-0164-2027
- Event id
- 99883
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Howmedica Osteonics Corp.
- Report date
- Oct 21, 2026
- Posted
- Oct 15, 2026
- Initiated
- Sep 16, 2026
- Center classification date
- Oct 15, 2026
- Product code
- FSM
- Device type
- Tray, Surgical, Instrument
- Reason
- Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
- Root cause
- Labeling design
- Quantity
- 605 trays
- Code info
- Catalog Number: 6543-6-506. GTIN: 07613327548082. All lot numbers used prior to the correction date of May 8, 2026 are impacted.
- Distribution
- These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Mahwah, NJ, United States